A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)

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This feasibility study will assess the effects of the Nativis Voyager therapy in patients with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine. Safety and clinical utility will be evaluated.

Condition or disease

Intervention/treatment

Glioblastoma Multiforme

Device: Nativis Voyager RFE Therapy

Detailed Description:

This feasibility study will assess the effects of the Nativis Voyager therapy in patients with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine (CCNU). Safety and clinical utility will be evaluated.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject has histologically confirmed diagnosis of GBM.

Subject has failed or intolerant to radiotherapy.

Subjects has failed or intolerant to temozolomide therapy.

Subject has progressive disease with at least one measureable lesion on MRI.

Subject is at least 18 years of age.

Subject has a KPS ≥ 60.

Subject has adequate organ and marrow function.

Exclusion Criteria:

Subject has received bevacizumab (Avastin).

Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine.

Subject is currently being treated with other investigational agents.

Subject has received other investigational therapy within the last 28 days.

Subject has received surgery within the last four weeks.

Subject is within 12 weeks of completion of radiation.

Subject has an active implantable or other electromagnetic device.

Subject has a metal implant, including a programmable shunt, in the head or neck that is incompatible with MRI.

Subject is known to be HIV positive.

Subject is pregnant, nursing or intends to become pregnant during the course of the study.